Korean J Obes.  2008 Jun;17(2):82-90.

Double-blind, Randomized, Multi-center, Comparative Clinical Trial of Sibutramine Mesilate with Sibutramine Hydrochloride for Evaluating Efficacy and Safety in Obese Patients

Affiliations
  • 1Department of Family Medicine, Ulsan University, Korea.
  • 2Department of Family Medicine, Catholic University, Korea.
  • 3Department of Family Medicine, Ajou University, Korea.
  • 4Department of Internal Medicine, Ajou University, Korea.
  • 5Department of Internal Medicine, Yonsei University, Korea.
  • 6Department of Internal Medicine, Hanyang University, Korea. choiwh@hanyang.ac.kr

Abstract

BACKGROUND: Sibutramine is an anti-obesity agent that inhibits reuptake of serotonin and norepinephrine. The aim of this study is to compare the efficacy and safety of sibutramine mesilate with sibutramine hydrochloride for evaluating efficacy and safety in obese patients.
METHODS
This study was a 12-week, double blind, multi-center, comparative clinical trial following a 2 week screening period. Eligible subjects had a body mass index greater than 30 kg/m2 or between 27 and 30 kg/m2 with controlled hypertension, diabetes or hyperlipidemia. Among 275 subjects, 218 subjects were randomized either to sibutramine mesilate or sibutramine hydrochloride in 6 centers.
RESULTS
After 12 weeks of treatment, 55.8% of sibutramine mesilate group and 53.5% of sibutramine hydrochloride group lost 5% or more of their body weight. Mean weight reduction at 12 weeks was 5.1 +/- 3.2 kg in sibutramine mesilate group and 5.0 +/- 4.1 kg in sibutramine hydrochloride group (P > 0.05). There were no significant differences in changes of weight, waist circumference, percent body fat and lipid profiles between the two groups (P > 0.05). Changes of blood pressure and pulse rate were not different in either groups. The drop out rate was not significantly different. Reported adverse events were similar in both groups with constipation as a highest frequency, 13.9% in sibutramine mesilate group and 10.0% in sibutramine hydrochloride group (P > 0.05).
CONCLUSION
A 12-week clinical trial showed evidence that efficacy and safety of sibutramine mesilate as an anti-obesity agent was not significantly different compared to those of sibutramine hydrochloride in obese subjects.

Keyword

Obesity; Efficacy; Safety; Clinical trial

MeSH Terms

Adipose Tissue
Blood Pressure
Body Mass Index
Body Weight
Constipation
Cyclobutanes
Heart Rate
Humans
Hyperlipidemias
Hypertension
Mass Screening
Mesylates
Norepinephrine
Obesity
Serotonin
Waist Circumference
Weight Loss
Cyclobutanes
Mesylates
Norepinephrine
Serotonin
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